Cleared Traditional

SEPTOCALCINE ULTRA

K920692 · Specialites Septodont · Dental
Apr 1992
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K920692 is an FDA 510(k) clearance for the SEPTOCALCINE ULTRA, a Liner, Cavity, Calcium Hydroxide (Class II — Special Controls, product code EJK), submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on April 21, 1992, 67 days after receiving the submission on February 14, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.3250.

Submission Details

510(k) Number K920692 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 1992
Decision Date April 21, 1992
Days to Decision 67 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJK — Liner, Cavity, Calcium Hydroxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3250

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